NCT00095082已完成3 期
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 447
- 试验地点
- 82
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 12 months
- •Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
- •HbA1c less than or equal to 11.0%
排除标准
- •Proliferative retinopathy or maculopathy
- •Recurrent major hypoglycaemia
- •Impaired hepatic or renal function
- •Cardiac problems or uncontrolled hypertension
结局指标
主要结局
HbA1c
时间窗: after 1 year trial period
次要结局
- Blood glucose
- Adverse events
- Body weight
- Hypoglycemia
- Insulin Treatment Satisfaction
研究者
研究点 (82)
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